Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF

NCT04592445 | Recruiting DMC FDA Device

• 1 other identifier: 09868
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 20

Brief Summary

The purpose of this clinical study is to evaluate the safety and early effectiveness of a catheter-based procedure that treats a nerve called the right greater splanchnic nerve. The study includes people who have heart failure with preserved ejection fraction (HFpEF). The goal is to learn whether this procedure, performed using the Satera Ablation System, may help improve symptoms and to better understand which patients may benefit most from this treatment in the future.

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF

Keywords

Heart Failure with Preserved Ejection Fraction (HFpEF); HFpEF; Greater Splanchnic Nerve; GSN

Outcome Measures

Primary Outcomes (3)

• Primary Safety Endpoint: Device or procedure related serious adverse events

  Evaluation of device or procedure-related serious adverse events at 1-month follow-up based on Clinical Events Committee (CEC) assessment

  1 Month

• Primary Efficacy Endpoint: KCCQ (6 months)

  Assessment of change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 6-month follow up visit

  Baseline through 6-months

• Primary Efficacy Endpoint: 6MWT (6 months)

  Assessment of change in Six Minute Walk Test (6MWT) from baseline to the 6-month follow up visit

  Baseline through 6 months

Secondary Outcomes (15)

• Pulmonary Capillary Wedge Pressure (PCWP)

  Baseline through 1-month

• Stress blood volume

  Baseline through 1-month

• NT-proBNP

  Baseline through 24-months

• KCCQ (24-months)

  Baseline through 24-months

• 6MWT (24-months)

  Baseline through 24-months

Other Outcomes (7)

• Exploratory endpoint: Heart failure related medication changes (24-months)

  Baseline through 24-months

• Exploratory Endpoint: Diuretic medication (24-months)

  Baseline through 24-months

• Exploratory Endpoint: Diastolic function (24-months)

  Baseline through 24-months

Study Arms (2)

Greater Splanchnic Nerve Ablation

ACTIVE COMPARATOR

After anesthesia is given, doctors will use the Satera Ablation System to reach a nerve called the right greater splanchnic nerve. Subjects receive catheter-based unilateral ablation of the right greater splanchnic nerve.

Device: Greater Splanchnic Nerve Ablation

Sham Control Arm

SHAM COMPARATOR

After anesthesia is given, doctors will place a small tube into a vein. The steps and length of the procedure will be similar to the Axon treatment procedure, but the study treatment will not be performed.

Device: Sham Control

Interventions

Sham Control DEVICE

During the sham procedure, a small needle puncture will be made in the groin or neck to access a vein using standard medical techniques. A short tube will be placed into the vein, similar to what is done for many heart procedures. The Satera catheter and treatment devices will not be inserted, and the nerve will not be treated. The procedure will take about the same amount of time as the treatment procedure.

Sham Control Arm

Greater Splanchnic Nerve Ablation DEVICE

The greater splanchnic nerve (GSN) ablation procedure begins with a small needle puncture in the groin or neck to access a vein, using methods that are commonly used for heart procedures. Doctors then guide thin tubes and wires through the vein to reach a nerve called the right greater splanchnic nerve. X-ray imaging is used to help the doctor see where the catheter is and guide it to the correct location. Once the catheter is in the right place, the doctor uses the device to treat the nerve using controlled heat.

Greater Splanchnic Nerve Ablation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic heart failure, defined as:
• Symptoms of HF requiring current (intermittent or continuous) treatment with diuretics for \>30 days, AND
• NYHA class II with a history of \>NYHA class II in the past year, NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening or signs of HF (any rales post cough, chest x-ray demonstrating pulmonary congestion), AND
• At least one of the following:
• i. ≥1 HF hospital admission (with HF as the primary diagnosis) including treatment with intravenous (IV) diuretics or urgent unplanned treatment with IV diuretics in healthcare facility within past 12 months, OR ii. NT-proBNP \>300 pg/ml in normal sinus rhythm (\>450 pg/ml in atrial fibrillation or flutter) within the past 6 months; BNP \>100 pg/ml in normal sinus rhythm (\>300 pg/ml in atrial fibrillation or flutter) within the past 6 months, OR iii. Right heart catheterization (RHC) with PCWP ≥ with PCWP ≥18 mmHg at rest or 25 mmHg during exercise at the time of the screening RHC.
• Ongoing stable GDMT HF management (unless unable to tolerate GDMT) and management of potential comorbidities according to the 2022 ACCF/AHA Guideline for the Management of Heart Failure (Class 1 and 2a recommendations), with no significant changes \[≥100% increase or ≥50% decrease\] for a minimum of 1 month (30 days) prior to screening, that is expected to be maintained without change for at least 6 months. Participants cannot have started a glucagon-like peptide (GLP)-1 or gastric inhibitory peptide (GIP) agonist within the last 6 months or plan to start a GLP-1 or GIP agonist within the ensuing 6 months after enrollment.
• LVEF ≥50% (site-determined by transthoracic echocardiography) within the past 6 months.
• Age ≥40 years.
• Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.

You may not qualify if:

• MI (type I) and/or percutaneous cardiac intervention within 3 months prior to screening; CABG in past 3 months prior to screening, or current indication for coronary revascularization.
• Cardiac resynchronization therapy initiated within 3 months prior to screening.
• Advanced heart failure defined as one or more of the following:
• ACC/AHA/ESC Stage D HF or non-ambulatory NYHA Class IV HF.
• Inotropic infusion (continuous or intermittent) within 6 months prior to screening.
• Subject is on the cardiac transplant waiting list.
• Presence of or prior history of mechanical circulatory support for HF.
• Poor left heart compliance as determined by pulse-wave Doppler transmitral early-to-late (E/A) ratio \>2.0 assessed by the screening echocardiogram. The Screening Committee will evaluate left heart function if the transmitral A velocity is not measurable or absent.
• Right heart dysfunction defined as tricuspid annular plane systolic excursion (TAPSE) \<12 mm or right ventricular (RV) fractional area change (FAC) \<25% assessed by the screening echocardiogram.
• Body mass index (BMI) \>45 kg/m2.
• minute walk test distance \<100 meters OR \>450 meters.
• Admission for HF within the 30 days prior to planned index procedure.
• Any known history of orthostatic hypotension or orthostatic hypotension at the time of screening (regardless of the presence of symptoms). Orthostatic hypotension is defined as a systolic blood pressure (BP) decrease of \>20 mmHg upon going from supine to standing position or undergoing treatment with Midodrine.
• Orthostatic pulse pressure change from supine to standing decrease of \>10mmHg in the absence of a HR increase \>15bpm
• Postural orthostatic tachycardia syndrome or preload insufficiency syndrome.

Sponsors & Collaborators

• Northwestern University Feinberg School of Medicine: collaborator
• Axon Therapies, Inc.: lead
• NAMSA: collaborator
• Cardiovascular Research Foundation, New York: collaborator

Study Sites (20)

Cardiology PC

Birmingham, Alabama, 35211, United States

COMPLETED

Arizona Cardiovascular Research Center

Phoenix, Arizona, 85016, United States

ACTIVE NOT RECRUITING

Scripps Health

La Jolla, California, 92037, United States

ACTIVE NOT RECRUITING

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Bluhm Cardiovascular Institute of Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Prairie Education and Research Cooperative

Springfield, Illinois, 62701, United States

ACTIVE NOT RECRUITING

Ascension St. Vincent - Cardiovascular Research Institute

Indianapolis, Indiana, 46260, United States

COMPLETED

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

RECRUITING

Michigan Medicine, University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

St. Louis Heart and Vascular

St Louis, Missouri, 63136, United States

RECRUITING

Weill Cornell Medicine

New York, New York, 10021, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

ACTIVE NOT RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Rochester General Hospital

Rochester, New York, 14621, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

ACTIVE NOT RECRUITING

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Study Officials

• Sanjiv S Shah, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judit Adorjan

CONTACT

16507221119; j.adorjan@axontherapies.com

Jennifer Moore, MS

CONTACT

jennifer@axontherapies.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subject and HF Cardiologist providing care are blinded. Interventionalist who performs the Index procedure is not. Research Coordinators may or may not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase I: Subjects randomized 1:1 (treatment to sham control); cross-over offered Phase II: Subjects randomized 2:1 (treatment to sham control): cross-over offered

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 19, 2020
• Study Start: December 18, 2020
• Primary Completion (Estimated): January 10, 2028
• Study Completion (Estimated): August 10, 2029
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)